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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cystometric gas (carbon-dioxide) on hydraulic device
510(k) Number K802374
Device Name ROBERTSON OBTURATION MONITOR INSUFFLA
Applicant
ENDOTEK CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ENDOTEK CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.1620
Classification Product Code
FAP  
Date Received09/29/1980
Decision Date 11/24/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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